11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112705·3M™ Victory Series™ Second Molar Bands, 905-117...
OHMEDA UNIVERSAL PAC
FDA 510(k)
FDA Class 2
·Anesthesiology
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 15, 2022
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2020
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·November 22, 2010
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LZG·July 1, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024